Clinical and Experimental Pediatrics

The Korean Pediatric Society (대한소아청소년과학회)
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The pharmacological treatment of patent ductus arteriosus in premature infants with respiratory distress syndrome: oral ibuprofen vs. indomethacin

호흡곤란 증후군 미숙아에서 동맥관 개존증의 약물 치료 : 경구용 ibuprofen과 indomethacin의 비교

  • Lee, Soo Jin (Department of Pediatrics, Ewha Womans University, School of Medicine) ;
  • Kim, Ji Young (Department of Pediatrics, Ewha Womans University, School of Medicine) ;
  • Park, Eun Ae (Department of Pediatrics, Ewha Womans University, School of Medicine) ;
  • Sohn, Sejung (Department of Pediatrics, Ewha Womans University, School of Medicine)
  • 이수진 (이화여자대학교 의학전문대학원 소아과학교실) ;
  • 김지영 (이화여자대학교 의학전문대학원 소아과학교실) ;
  • 박은애 (이화여자대학교 의학전문대학원 소아과학교실) ;
  • 손세정 (이화여자대학교 의학전문대학원 소아과학교실)
  • Received : 2007.10.16
  • Accepted : 2008.08.05
  • Published : 2008.09.15
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Abstract

Purpose : Indomethacin is widely used for the prophylaxis and treatment of patent ductus arteriosus (PDA); however, it is associated with side effects such as renal failure, intraventricular hemorrhage, and gastrointestinal bleeding. Intravenous ibuprofen has been shown to be as effective as indomethacin in prompting PDA closure. If treatment with oral ibuprofen is as effective as indomethacin, it would have the advantages of greater availability, simpler administration, and lower cost. We conducted this study to compare the efficacy and side effects of indomethacin with those of oral ibuprofen, vis-$\grave{a}$-vis on the pharmacological closure of PDA. Methods : As a randomized double-blind study, 34 preterm infants with respiratory distress syndrome and hemodynamically significant PDA were treated with either intravenous indomethacin or oral ibuprofen. Echocardiography was performed by one cardiologist who was blind to the treatment that any given infant received. The rate of ductal closure, the need for additional drug treatment or surgical ligation, clinical outcome, and the side effects of drug treatment were compared. Results : Ductal closure occurred in 16 of 18 patients (88.9%) from the indomethacin group and in 14 of 16 patients (87.5%) from the ibuprofen group (P>0.05). Three patients in the indomethacin group and four in the ibuprofen group required a second drug treatment (P>0.05). Three patients (i.e., one patient in the indomethacin group and two in the ibuprofen group) underwent surgical ligation (P>0.05). Between the two groups, there was no significant difference vis-$\grave{a}$-vis in side effects or clinical outcome. Conclusion : Compared to indomethacin, oral ibuprofen has the advantages of simpler administration and lower cost, while being as effective; in addition, there are no differences between the two drug treatments with regards to side effects or clinical outcomes. Therefore, the widespread use of oral ibuprofen should be considered in treating PDA in preterm infants.

목 적 : Indomethacin은 동맥관 개존증의 예방 및 치료에 널리 사용되고 있다. 그러나 indomethacin은 신부전, 괴사성 장염, 뇌실내 출혈, 위장관 출혈 등의 합병증을 유발한다. Ibuprofen은 동맥관 개존증을 치료하는데 indomethacin 만큼 효과적이며 신장, 장간막, 뇌혈류에 영향을 주지 않는다. 동맥관 치료에 있어서 경구용 ibuprofen의 효과가 indomethacin과 동일하다면 경구용 ibuprofen은 투여가 간단하고 비용이 저렴한 장점이 있다. 이 연구에서는 미숙아 동맥관 개존증의 치료에서 indomethacin과 경구용 ibuprofen의 효과와 부작용을 비교하였다. 방 법 : 무작위 이중 맹검법으로 미숙아 중 호흡곤란 증후군을 진단받고 심초음파에서 혈역학적으로 의미 있는 동맥관 개존증이 확인된 환아 34명을 대상으로 18명에게는 indomethacin 정맥 투여나 ibuprofen 경구 투여를 시행하였다. 심초음파를 실시하는 소아심장 전문의는 환아의 투약 종류를 모르는 상태에서 연구가 진행되었으며 동맥관 폐쇄율, 추가적인 약물 치료나 수술의 필요성, 약물의 부작용 및 환아의 임상 경과를 비교하였다. 결 과 : 동맥관 폐쇄율은 indomethacin군은 18명 중 16명(88.9%), ibuprofen군은 16명 중 14명(87.5%)이었다(P>0.05). 2차로 약물 치료가 필요한 환아는 indomethacin군은 3명, ibuprofen군에서는 4명이었다(P>0.05). 3명(indomethacin군에서 1명, ibuprofen군에서 2명)은 수술적 치료를 시행하였다(P>0.05). 약물 치료 후의 임상경과와 부작용은 두 군 간에 통계학적으로 유의한 차이가 없었다. 결 론 : 경구용 ibuprofen은 indomethacin에 비해 효능과 부작용 및 임상 경과에 차이가 없고 투여가 간단하고 비용 면에서는 월등한 이득이 있으므로 호흡곤란 증후군을 가진 미숙아의 동맥관 개존증 치료에 있어서 경구용 ibuprofen의 보편적 사용을 고려할 수 있을 것이다.

Keywords

References

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